Reported May 11, 2016 · Terminated

Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

Medtronic Sofamor Danek USA, Inc. - Dallas Distribution

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution · 4620 N Beach St · Haltom City, TX · 76137-3219

Is this the product you have?

  • Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Lot codes and dates
  • Product Catalog Number10BA40D
  • Lot NumberH5237248
Amount recalled
81 tools

Why it was recalled

Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 16, 2017 · Data as of Sep 19, 5:59 PM UTC

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